Analytical Associate Scientist
The qualified candidate will join the Technology Transfer Department to enable the optimization, development, validation and application of analytical methods to characterize the identity and purity of drug substances and drug products.
· Optimize or develop analytical methods for pre-clinical and clinical stage biotherapeutics characterizations.
· Modify or write Standard Operation Procedure (SOP) to characterize the identity and purity of DS (drug substances) and DP (drug products).
· Develop analytical methods for intermediates as part of PAT (Process Analytical Technology)
· Involved in Technology Transfer from other companies.
· Perform all experiments under applicable safety and regulatory compliances.
· Generate high quality results in support of analytical testing of growing drug pipeline.
· Document data/results according to applicable compliances, such as GLP and GMP.
· Effective communication of data/results through written documentation and oral presentations.
· Accountable for completing the assigned tasks and communicate results in a timely manner.
· Perform other duties as assigned.
· A master degree in analytical science or equivalent, with 2-5 years of experience within a biopharmaceutical industry analytical laboratory.
· Strong hands-on experience with HPLC (SEC, IEX, RP), LC-MS (peptide mapping and
N-linked glycan) and CE (cIEF and CE-SDS).
· Extensive experience of SDS-PAGE and western blot.
· Ability to work independently，with minimal supervision，and to manage multiple projects at one time.
· Good written and oral communication skills in English.
· Eager and quick to learn, self-driven and motivated.